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The Department of Neurology offers comprehensive consultation, evaluation and treatment services for adults and children with neurological disorders, through its clinical facilities at the University of Washington Medical Center, Harborview Medical Center, Northwest Hospital and Medical Center, VA Puget Sound Health Care System and Seattle Children's Hospital and Regional Medical Center. Through our commitment to research, we continue to gain insight and understanding into the normal and abnormal functions of the human nervous system and how to care for related disorders. We are then able to share the knowledge gained and results of this research with our colleagues at the University, across the nation, and around the world. The Neurology Clerkship and Residency Training Programs represent significant foci of the Department's efforts. We are extremely proud of our programs, which regularly receives applications for training from around the world. Clinical exposure is outstanding, teaching is a top priority, research and collaborative opportunities are abundant, and our faculty are friendly and approachable.
The Department of Neurology has been a center of clinical and academic excellence since 1995, and has a mission that includes meeting the health-care needs of patients with neurological issues, advancing knowledge through research in the clinical and basic neurosciences and training the next generation of neurologists in our residency program through its clinical facilities at the University of Washington Medical Center, Harborview Medical Center, VA Puget Sound Health Care System and Children's Hospital and Regional Medical Center.
The University of Washington Alzheimer's Disease Research Center (ADRC) currently has an outstanding opportunity for a RESEARCH COORDINATOR to coordinate and manage its clinical trials program and serve as the primary coordinator for the ADRC's Clinical Core. The UW ADRC is one of 31 Alzheimer's
Disease Centers across the United States with funding from the National Institute on Aging (NIA). During the current five-year funding cycle, the UW ADRC's mission is to advance precision medicine for the molecular and clinical complexity of Alzheimer's disease (AD). The UW ADRC will advance research in
genetic risk, develop neuroimaging and biomarkers for pre-clinical detection, discover novel therapeutics tailored to an individual's molecular drivers ofdisease and facilitate interventional trials in subjects with or at risk for developing AD.
The Research Coordinator (RC) will have primary responsibility for managing research programs surrounding Alzheimer's disease, playing an integral role in initiating, coordinating, organizing, and maintaining interventional trials. The RC will be responsible for developing statements of work (SOWs) including
guidance on research study design in coordination with the principal investigator (PI), protocol development, reporting, data management, and personnel management. The RC will manage a $1.5 M interventional pharmaceutical trial for Alzheimer's disease under the supervision of study PI, as well as
manage and supervise UW ADRC clinical core research staff. The RC will work with the PI's budget manager to produce project budgets for review and approval by the PI.
The RC will be directly involved in making recommendations and study design decisions that impact ADRC operations. As such, the RC will interact with a variety of populations, inlcuding faculty investigators, Center staff, clinical research subjects with varying levels of cognitive ability, family members of
clinical research subjects, and associated external organizations, including Academic Medical Centers. The RC will direct and coordinate the flow of highly sensitive patient information and research data. The
position will require the use of independent judgement, problem solving skills, project and time management, and delegated authority to ensure that each of the research projects remain on deadline for successful execution of benchmarked deliverables. The RC will assist (and lead, if applicable) in obtaining grant funding from internal and external agencies, including industry sponsors, that will directly impact the growth, sustainability, and ultimate success of the clinical trials program for the ADRC. Indeed, the position will require interaction with pharmaceutical trial sponsors, FDA, UW Medicine CRBB, UW IRB, OSP, and contracting departments within the UW and outside sponsors. The position will supervise operations of staff at the clinical research offices of the ADRC on the Harborview Medical Center (HMC) campus Ninth and Jefferson Building.
This position will impact the ADRC by directing the workflow of clinical trials from inception and design to billing and implementation. The position will support and augment the on-going research being done at the UW ADRC. This position will be pivotal in the introduction of phase III clinical trials in AD and related dementias to the HMC Clinical Core site. Indeed, the position's reach will result in increased visibility of the ADRC and University of Washington as a whole through exposure to and interactions with industry sponsors and national Alzheimer's Disease Centers (ADC).
This position supports the University's vision and mission by coordinating research studies of internal investigators with outside funding agencies to introduce phase III clinical trials for AD, contributing to the knowledge gained from each study, and facilitating the belief that discovery is at the heart of the University.
Research Project Administration and Management :
Oversee and/or conduct a broad range of research activities associated with each research project including recruitment, screening, consenting, administering neuropsychological testing, and specimen processing.
Independently develop and implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).
Design, develop, document and maintain policies and procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice (GCP) guidelines.
Manage budgets, develop new budget for ongoing ammendments and new trials, trial startup. Interface with CRBB and sponsors for budget management.
Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives.
Supervise and manage team of study research study coordinators and research assistants, including overseeing screening/treatment visits between clinicians, neuropsychologist, nursing and other staff.
Oversee training, performance monitoring, and supervision of research staff, including providing major input to staffing of overall project teams and building team and staff to optimize efficiency and meet deadlines.
Design, document and implement procedures for audits and site monitor visits to assure protocol compliance and to ensure research data quality.
Ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Assist principal investigator by planning and conducting protocol of medical team research.
Manage clinical trial vendors and ensure queries and reports are resolved or completed in a timely manner.
Implement research protocols at HMC and UWMC, integrating research and clinical requirements to ensure patient safety and protocol compliance.
Manage data collection across multiple UW sites, liaising with ADRC and the Memory Brain Wellness Clinic at HMC.
Monitor data quality control to ensure adherence to study protocol.
Coordinate execution of and monitor project deliverables as dictated by established timeline, including recruitment and enrollment targets.
Prepare updates to director of program operations on each project's progress.
Interpret and apply study protocols.
Assess current clinical or administrative operations within sites to identify and establish successful workflow for research subject recruitment.
Perform initial and on-going needs assessments for optimal site participation and subject recruitment.
Participate in refining and updating research designs and assembling data collection in coordination with principal investigator to ensure timely delivery of results.